A prospective randomized phase III trial comparing trimodality therapy (cis-platin, 5-FU, radiotherapy, and surgery) to surgery alone for esophageal cancer

Originating Group

CALGB 9781

P.I.: Dr. Mark Krasna

Participating Groups

NCCTG C9781 Dr. Daniel Miller

ECOG C9781 Dr. Richard Feins

RTOG 97-16 Dr. Robert J. Ginsberg

Objectives

1. To compare overall 5 year survival rates between the two treatment arms.
2. To compare treatment failure at five years between the two treatment arms.
3. To assess and compare the toxicities of each approach.
4. To compare the incidence and pattern of local(gastric or esophageal bed or regional lymph nodes) and distant(supraclavicular lymph nodde, liver, peritoneal carcinomatosis,or lung, brain, etc.) recurrence.
5. To evaluate the prognostic ability of noninvasive and minimally invasive pretreatment staging with regard to survival and recurrence.
6. To evaluate the ability of pre-resection adjuvant chemotherapy with concomitant radiation therapy to render tumors to lower stages. This comparison will be made between pre-study and pre-operative CT scans.
7. to evaluate the impact of positive lymph nodes on survival and recurrence.

Eligibility

1. Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20cm) or gastroesophageal junction.
2. No distant metastases. Any lesions suspicious as metastases on CT should be followed with testing by ultrasound, MRI, or biopsy to prove eligibility.
3. Tumor must be considered surgically resectable (T1-3,NX).
4. Patients with the following are eligible: regional thoracic lymph node (N1) metastases, lymph node metastases level 15-20 < or equal to 1.5cm by CT, supraclavicular nodes < or equal to 1.5cm by CT that are not palpable on clinical exam.
5. Patients with the following are ineligible: radiographically positive lymph nodes levels 15-20 which are >1.5cm, or palpable supraclavicular nodes or supraclavicular nodes which are radiographically positive, i.e. >1.cm.

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