Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma

NCT02773485 | Unknown Phase 3 DMC

• 1 other identifier: TMC IRB 1457
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates impact of high dose radiation on overall survival in patients with unresectable nonmetastatic cholangiocarcinoma. The study randomizes patient between systemic chemotherapy alone and systemic chemotherapy and high dose radiation

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  The trial is designed to assess a 36 month benefit overall survival

  3 years from completion of study

Secondary Outcomes (5)

• loco-regional progression free survival

  3 years from completion of accrual

• Toxicity Assessment

  upto 3 years

• Quality of Life Assessment of patients over a period of time

  3 years from completion of accrual

• Surgical Resectability Rates

  6 weeks from completion of primary treatment

• cause specific survival

  3 years from completion of accrual

Study Arms (2)

Systemic Chemotherapy

ACTIVE COMPARATOR

Irrespective of arm allocation Baseline Positron Emission Tomography(PET) scan and hepatic function assessment will be done. Those randomized to this arm will receive systemic chemotherapy delivered on day 1 and 8 every 3 weekly, with gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2. After first 4 cycles patients will undergo repeat Contrast Enhanced Computed Tomography(CECT)/PET scan. If CECT/PET scan shows stable/ responding disease then patients will continue to receive the same chemotherapy. In case of locally progressive/ systemic disease on chemotherapy patients may be considered for second line palliative chemotherapy or best supportive care. The use of radical chemoradiation is not allowed on disease progression in this arm. However palliative radiation may be used.

Drug: Systemic chemotherapy

Chemotherapy and radiation

EXPERIMENTAL

In those randomized to radiation arm with receive high dose radiation with Intensity Modulated Radiation Therapy in addition to systemic and concurrent chemotherapy. The gross tumor will comprise the high dose volume. The adjacent areas of suspected microscopic disease will form the low dose volume. When only external radiation is used the aim will be to deliver 52.5-60 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2) .

Radiation: High Dose Radiation; Drug: Systemic chemotherapy

Interventions

High Dose Radiation RADIATION

The aim will be to deliver 52.5-60 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2) .

Also known as: Radiation

Chemotherapy and radiation

Systemic chemotherapy DRUG

This arm will receive maximum 8 cycles of gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 delivered on day 1 and 8 every 3 weekly.

Also known as: Gemcitabine and Cisplatin regimen

Chemotherapy and radiation; Systemic Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Performance Status 0-2
• Tissue diagnosis of adenocarcinoma of the biliary tract. Wherever tissue diagnosis is not feasible in spite of repeated attempts a multidisciplinary consensus on clinicoradiological diagnosis of cholangiocarcinoma (CA 19-9= 100mg/ml with a radiological evidence of malignant stricture) should be made and patients consent should be available for treatment without tissue diagnosis.
• Unresectable disease as determined by hepatobiliary surgical team.
• No evidence of peritoneal or distant metastasis.
• No radiological evidence of paraaortic nodal disease.
• Child A or Child B (score 7)
• Ability to tolerate radical treatment.

You may not qualify if:

• Multicentric intrahepatic cholangiocarcinoma (however adjacent satellite lesions are permitted)
• Inability to deliver safe radiation due to high tumor/ liver ratio.
• Active cholangitis.
• Expected Survival\<6 months.
• Unresolved biliary tract obstruction.
• Inability in deliver systemic chemotherapy (persistent bilirubin\>3)

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Radiation; Neoadjuvant Therapy; Gemcitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Physical Phenomena; Combined Modality Therapy; Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Supriya Chopra, MD

  ACTREC,Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Supriya Chopra, MD

CONTACT

09930958309; supriyasastri@gmail.com

Supriya Chopra, MD

CONTACT

09930958309; schopra@actrec.gov.in

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Radiation Oncology

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: May 16, 2016
• Study Start: May 1, 2015
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

IN (1)