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RecruitingLast updated: 28 March 2024

PALEO: This study is investigating the effectiveness of a radiotherapy, immunotherapy and chemotherapy treatment regimen in people with oesophageal cancer that has spread to another area of the bodyPhase II clinical trial of chemoradioimmunotherapy for the ALleviation of oEsOphageal cancer complications

Clinical summary

Summary

Eligible participants will receive 10 treatments of radiation therapy to the primary oesophageal cancer, with one treatment given on each working day for 2 weeks.

In addition, all participants will receive chemotherapy (including carboplatin and paclitaxel) given intravenously once per week for the same 2 weeks as the radiation therapy.

Durvalumab (immunotherapy) will be given intravenously every 4 weeks from the beginning of radiation therapy. After this, participants will continue to receive durvalumab intravenously once every 4 weeks for up to 24 months.

If the participants have a metastatic tumour, they will also be given 3 doses of radiation therapy in one week. This radiation therapy will be received 4 weeks after the initial radiation therapy is completed.

It is hoped that this trial can help determine if this chemotherapy with immunotherapy and radiation therapy combination is effective in increasing the ability of the body's immune system to prevent worsening of the cancer and improve swallowing.

Conditions

This trial is treating patients with cancer of the oesophagus or gastro-oesophageal junction

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

II

Trial Acronym

PALEO

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Varian Medical Systems, Inc,Australasian Gastro-Intestinal Trials Group (AGITG)

Scientific Title

Phase II clinical trial of chemoradioimmunotherapy for the ALleviation of oEsOphageal cancer complications

Eligibility

Inclusion

1. Males and females > 18 years of age.
2. Biopsy proven carcinoma of the oesophagus or gastro-oesophageal junction
3. Oligometastatic disease (1-5 lesions outside the primary tumour radiotherapy field on FDG-PET scan), or locoregionally advanced disease unsuitable for either surgical resection or radical chemoradiotherapy
4. Symptomatic dysphagia (Mellow score greater than 0)
5. ECOG performance status 0-2
6. Anticipated life expectancy of greater than 12 weeks.
7. Body weight of greater than 30kg.
8. Adequate bone marrow function, with values within the ranges specified below. Blood transfusions are permissible.
a. White blood cell count greater than or equal to 2 x 109/L
b. Absolute neutrophil count greater than or equal to 1.5 x 109/L
c. Platelets greater than or equal to 100 x 109/L
d. Haemoglobin greater than or equal to 90g/L
9. Adequate liver function, with values within the ranges specified below:
a. Alanine transferase less than or equal to 2.5 x upper limit of normal (ULN)
b. Aspartate transferase less than or equal to 2.5 x ULN
c. Total bilirubin less than or equal to 1.5 x ULN (except patients with Gilbert’s Syndrome, who can have total bilirubin less than or equal to 5 x ULN)
10. Adequate renal function, with values within the ranges specified below. Note that an estimated renal function of greater than or equal to125mL/min by the Cockroft-Gault formula must not be used for carboplatin dosing, and must instead be determined using a direct method.
a. Serum creatinine less than or equal to 1.5 x ULN
b. Creatinine clearance (CrCl) greater than or equal to 40 mL/min using Cockroft-Gault formula
11. Tumour tissue (formalin-fixed, paraffin embedded) should be available for PD-L1 and mismatch repair (MMR) protein expression and can be provided as a block or slides (archival tissue is acceptable). Blocks prepared from cytological samples, where tumour cell number is sufficient, are also acceptable. Patients will not be selected by PD-L1 or MMR status.
12. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
13. Signed, written and informed consent.

Exclusion

1. Bulky or organ-threatening metastatic disease requiring upfront higher dose chemotherapy in the judgement of the treating clinician.
2. Known tumour HER2 positivity (IHC 2+ or more and HER2 gene amplification on in situ hybridisation)
3. Previous systemic therapy for oesophageal or GOJ carcinoma.
4. Previous thoracic radiotherapy. Prior palliative radiotherapy to bony metastases is permitted.
5. Oesophageal stent in situ.
6. Known tracheo-oesophageal fistula.
7. Leptomeningeal or uncontrolled brain metastases. Controlled brain metastases are those which have been treated and are radiologically and/or clinically stable, and the patient is asymptomatic and does not require steroids.
8. Major surgical procedure (as defined by the Investigator) within 28 days prior to first day of study treatment. Note: Local surgery of isolated lesions for palliative intent is permitted.
9. History of another malignancy within the last 3 years, with the exception of adequately treated non-melanomatous skin cancer, carcinoma in situ and superficial transitional cell carcinoma of the bladder.
10. Prior therapy with an anti-PD1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
11. Sensory neuropathy of grade 2 or higher severity per CTCAE v5.0
12. History of allergy or hypersensitivity to study drug components, or other contraindications to any of the study drugs. Active or prior documented autoimmune disorders (including inflammatory bowel disease [e.g., ulcerative colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc). Patients with the following conditions are exceptions to this criterion:
a. Vitiligo or alopecia.
b. Hypothyroidism (e.g., following Hashimoto syndrome) stable on thyroid hormone replacement.
c. Any chronic skin condition (e.g. psoriasis) that does not require systemic therapy.
d. Type 1 diabetes mellitus.
e. Coeliac disease controlled by diet alone.
13. Patients without active autoimmune disease in the last 5 years may also be included but only after consultation with the Chief Principal Investigators.Any condition requiring continuous systemic treatment with either regular corticosteroids (>10mg daily prednisone or equivalent dose of an alternative corticosteroid) or other immunosuppressive medications within 14 days of study drug administration. Intranasal, inhaled or topical steroids, and adrenal replacement steroid doses >10mg daily oral prednisone equivalent, are permitted in the absence of active autoimmune disease.
14. Positive test for hepatitis B surface antigen (HBsAg) indicating acute or chronic infection. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible.
15. Positive test for hepatitis C virus antibody (HCV antibody) , unless polymerase chain reaction is negative for HCV RNA.
16. History of other significant, or active, infection, including HIV or tuberculosis (TB). HIV testing is not mandatory unless clinically indicated. Clinical evaluation for active TB may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice.
17. Receipt of a transplanted solid organ (kidney, liver, heart or lung) or of an allogeneic bone marrow transplant.
18. Receipt of a live attenuated vaccine within 30 days prior to registration.
19. Use of alternative or traditional medicines within 14 days prior to registration.
20. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events or compromise the ability of the patient to give written informed consent.
21. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception to avoid pregnancy for 90 days after the last dose of durvalumab. Women of childbearing potential must have a negative pregnancy test within 24 hours prior to trial registration. Men must have been surgically sterilized or use a double barrier method of contraception if they are sexually active with a woman of childbearing potential for a period of 180 days after the last dose of durvalumab and chemotherapy, or 90 days after the last dose of durvalumab monotherapy (whichever is the longer time period). Sperm donation is not permitted for 180 days after the last dose of durvalumab and chemotherapy, or 90 days after the last dose of durvalumab monotherapy (whichever is the longer time period).

Inclusion

  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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