Clinical trial

Randomized Phase II Study of Preoperative Combined Modality Paclitaxel / Cisplatin / RT or Irinotecan / Cisplatin / RT Followed by Postoperative Chemotherapy With the Same Agents in Operable Adenocarcinoma of the Esophagus

Name

CDR0000069309

Description

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before and after surgery may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer.

Trial arms

Trial start

2002-08-15

Estimated PCD

2009-09-01

Trial end

2009-10-01

Status

Completed

Phase

Early phase I

Treatment

cisplatin

Days 1 - 35 : Cisplatin 30 mg/m² days 1, 8, 15, 22, 29 Days 63 - 77 : cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles

Arms:

Cisplatin / Irinotecan / Radiation therapy (Arm A), Paclitaxel / Cisplatin / Radiation therapy (Arm B)

Other names:

cis-platinum, platinum, Platinol, Platinol-AQ, DDP, CDDP, DACP, NSC 119875

irinotecan hydrochloride

Days 1 - 35 : Irinotecan 65 mg/m² days 1, 8, 22, 29 Days 63 - 77 : irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles

Arms:

Cisplatin / Irinotecan / Radiation therapy (Arm A)

Other names:

Camptothecin-11, CPT-11, Camptosar

paclitaxel

Days 1 - 35 : Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29 Days 63 - 77 : paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles

Arms:

Paclitaxel / Cisplatin / Radiation therapy (Arm B)

Other names:

Taxol, NSC 125973

conventional surgery

The type of resection (lvor-Lewis, Transhiatal, etc.) was left to the discretion of the operating surgeon. One lymph node dissection was required.

Arms:

Cisplatin / Irinotecan / Radiation therapy (Arm A), Paclitaxel / Cisplatin / Radiation therapy (Arm B)

radiation therapy

The total dose to the prescription point was 4500 cGy given in 25 fractions. The patient was treated with one fraction per day with all fields treated per day. 180 cGy was delivered to the isocenter. If the dose to the supraclavicular fossa (SCF) was less than 4500 cGy, a localized photon or electron boost was allowed in order to increase the SCF dose to 4500 cGy, specified at 3 cm depth from the anterior skin surface.

Arms:

Cisplatin / Irinotecan / Radiation therapy (Arm A), Paclitaxel / Cisplatin / Radiation therapy (Arm B)

Size

Primary endpoint

Pathologic Complete Response Rate

approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry

Eligibility criteria

Inclusion Criteria: * Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or gastroesophageal junction * Stage T2-3, N0, M0 OR * Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis) * Tumor must be considered surgically resectable (T1-3, but not T4) * Age\>=18 years * ECOG Performance status 0-1 * Adequate hematopoietic, hepatic, renal functions defined by the following within 4 weeks prior to randomization: * Granulocyte count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * Prior curatively treated malignancy allowed if currently disease-free and survival prognosis is more than 5 years * Fertile patients must use effective contraception * Endoscopy with biopsy and dilation allowed Exclusion Criteria: * Tumor extends more than 2 cm into the cardia * Pregnant or nursing * Other concurrent illness that would preclude study therapy or surgical resection * Concurrent filgrastim (G-CSF) during study radiotherapy * Prior chemotherapy * Prior radiotherapy * Prior surgery

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 97, 'type': 'ACTUAL'}}

Updated at

2023-06-28

1 organization

2 products

1 drug

2 indications

Organization

Eastern Cooperative Oncology Group

Product

Indication

Indication

Product

Drug